510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K090827 | Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay | Becton Dickinson & Co | LSL | Class II | |
| K090588 | Power Processor Sample Processing System with Generic Connection Module, Model: 4210 | Siemens Healthcare Diagnostics Inc. | CDD | Class II | |
| K090567 | Orthodontic Ceramic Bracket | Star Dentech Korea., Corp | NJM | Class II | |
| K090531 | Radcalc Software, Version 6.0 | Lifeline Software, Inc. | MUJ | Class II | |
| K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | OLO | Class II | |
| K090321 | Ric Conformal Source, Model 100 | Ri Consultants, LLC | ONL | Class II | |
| K083322 | Neurometrix Bioamplifier | Neurometrix, Inc. | GWL | Class II | |
| K083118 | Spinal USA Anterior Cervical Interbody Fusion Device | Spinal USA | ODP | Class II | |
| K082858 | Exsept Wc Antimicrobial Skin and Wound Cleanser | Alcavis International, Inc. | FQH | Class II | |
| K082824 | Fluid Filled Teether | Kids II, Inc. | KKO | Class II | |
| K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,Rp-1, Rg-1 | Intra-Lock International | MQV | Class II | |
| K091374 | Ge Logiq I/e & Vivid E Compact Ultrasound | GE Medical Systems China Co., Ltd. | IYO | Class II | |
| K090257 | Immulite 2000 3Gallergy Specific Ige Assay Kit | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K081122 | Fusion Medical Cannulated Screw System | John Riccio | HWC | Class II | |
| K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | Terumo Corp. | OCY | Class II | |
| K091250 | Diagnostic Catheter System | Medtronic, Inc. | EOQ | Class II | |
| K091099 | C-Port - Hp Power Injectable Port | PHS Medical GmbH | LJT | Class II | |
| K090676 | Montblanc Implantology and Omnipratique Contra-Angles | Anthogyr | EFA | Class I | |
| K090665 | Emboshield Nav6 Embolic Protection System-Small/large, Model 22437-19/22438-19 | Abbott Vascular-Vascular Solutions | NTE | Class II | |
| K090469 | Carestream Dryview 5850 Laser Imager | Eastman Kodak Company | LMC | Class II | |
| K090461 | Image-Arena 4.0 and Ia Applications 2D Cardiac Performance Analysis 1.0 | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K090452 | Neoss Implant System 03.25 | Neoss, Ltd. | DZE | Class II | |
| K090340 | Freehand | Prosurgics Limited | GCJ | Class II | |
| K090330 | Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models K1270, Kc270 | Siemens Healthcare Diagnostics Inc. | JFY | Class II | |
| K090208 | Biopro Femoral Heads | Biopro, Inc. | JDI | Class II | |
| K090155 | Caas Mr Flow 1.0 | PIE Medical Imaging B.V. | LLZ | Class II | |
| K090037 | Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector, Model Pocketecg | Medicalgorithmics sp Z.O.O. | DSI | Class II | |
| K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | DQY | Class II | |
| K083805 | Ankylos C/x Dental Implant System | Dentsply Intl. | DZE | Class II | |
| K083514 | Terumo Syringe With/without Needle | Terumo Europe N.V. | FMF | Class II | |
| K083441 | Freedom Stim 100 and 200 Electrode and Leadwire Extension | Motion Medical Products, LLC | GXY | Class II | |
| K083328 | Ensite System, Model Ee3000, and Ensite Navx Surface Electrode, Model En0010 | Abbott Medical | DQK | Class II | |
| K082589 | Barosense Endogastric Tube (Egt), Model F0034 | Barosense, Inc. | FED | Class II | |
| K082455 | Rectangular Multiplace Hyperbaric Chamber | Gulf Coast Hyperbarics, Inc. | CBF | Class II | |
| K082111 | Straumann Membragel | Straumann USA, LLC | NPK | Class II | |
| K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | DePuy Spine, Inc. | MAX | Class II | |
| K091023 | Metamorphosis | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K090815 | Percutaneous Discectomy System | Laurimed, LLC | HRX | Class II | |
| K090549 | Synthes Synapse Transconnector | Synthes GmbH | KWP | Class II | |
| K090457 | Oralube | Pulpdent Corporation | ONK | Class I | |
| K083751 | Invacare Tpoc Portable Concentrator, Model Tpoc100 | Invacare GmbH | CAW | Class II | |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter Assay | Ortho-Clinical Diagnostics, Inc. | JZO | Class II | |
| K082817 | Primus Steam Sterilizer, Models Pss5-G-1 and Pss5-M | PRIMUS Sterilizer Company LLC | FLE | Class II | |
| K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | MQV | Class II | |
| K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K091133 | Aplion Topical Care System | Aplion Medical Corporation | NAD | Class I | |
| K090736 | Power Infuser, Model M100b-3A | ZOLL Medical Corporation | FRN | Class II | |
| K090725 | Oculus Microcyn Wound Gel | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K090530 | Spin-Loc Suture Anchor System Fg-0302-01,Fg-0305-01 | Ross Creek Medical, Inc. | MBI | Class II | |
| K090440 | Hinge Pediatric Plating System | Orthopediatrics Canada ULC | HRS | Class II |